Lactic Acidosis During and After Seizures

NCT01833247 | Completed Results

• 1 other identifier: Stanford Epilepsy IRB 21989
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This project looks at the time course of lactic acid rise (if any) after seizures. Salivary and capillary lactic acid are tested. This type of measurement may be useful in signalling the occurrence or recent history of a seizure.

Conditions

Epilepsy

Keywords

epilepsy; lactic acid; saliva; postictal

Outcome Measures

Primary Outcomes (3)

• Salivary Lactic Acid Levels With Seizures

  The investigators will assess the salivary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in saliva , immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.

  Within 10 minutes of end of the seizure

• Capillary Lactic Acid Levels With Seizures

  The investigators will assess the capillary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in blood, within 10 minutes after the end of a seizure. Units of measurement will be mM/L. Baseline lactate serum level is expected to be less than 2.2 mM/L.

  Within 10 minutes of end of the seizure

• Intravenous Lactic Acid Levels With Seizures

  The investigators will assess the intravenous lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in serum collected by IV, immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.

  Within 10 minutes of end of the seizure

Study Arms (1)

Epilepsy inpatients

Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age range will be 18-75, men and women, all ethnic backgrounds to be eligible. Eligible population will be determined by who gets admitted to the epilepsy monitoring unit with a history of generalized tonic-clonic seizures.

You may qualify if:

• Age 18-75 inclusive.
• History of at least one generalized tonic-clonic (grand mal) seizure prior to enrollment in the study.
• Undergoing monitoring in the Stanford Epilepsy Monitoring Unit.

You may not qualify if:

• Not pregnant.
• Inability to understand and sign the consent form.
• No known history of mitochondrial disease or other metabolic disorders expected to affect blood lactate.
• No known peripheral vascular disease affecting blood circulation to the fingers.
• No painful peripheral neuropathy.
• No Raynaud's disease or phenomenon.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital

Stanford, California, 94305-5235, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Salivary lactic acid levels were difficult to reliably obtain with commercial devices designed to measure blood salivary levels. Because of low reliability, we did not pursue the study.

Results Point of Contact

• Title: Robert S. Fisher, MD, PhD
• Organization: Stanford University Department of Neurology

robert.fisher@stanford.edu

650-7215289

Study Officials

• Robert S Fisher, MD, PhD

  Stanford University Department of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 16, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 5, 2017
• Results First Posted: May 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)